背景:辅助治疗对于肌肉浸润性膀胱癌(MIBC)根治性膀胱切除术(RC)后手术切缘(PSM)阳性的患者没有明确的作用。我们研究的目的是描述局部区域无复发生存率(LRFS),无转移生存率(MFS),无复发生存率(RFS),癌症特异性生存率(CSS)和总生存率(OS),并确定MIBCRC后PSM患者的每个终点的预测因子。
方法:对2000年1月至2018年12月在10个三级转诊中心接受MIBC治疗的394例PSM患者进行了一项合作回顾性队列研究。接受围手术期放疗的患者被排除在研究之外。使用Kaplan-Meier曲线估计患者生存。Cox回归分析用于确定生存预测因子。
结果:手术的中位年龄为70岁(IQR62-76),其中129(33%)和204(52%)患者患有pT3和pT4肿瘤,分别。148例(38%)淋巴结转移(pN+)。在283例(72%)患者中发现软组织PSM,尿道PSM65例(16.5%),发现输尿管PSM73例(18.5%)。中位随访时间为44个月(95%CI32-60)。LRFS中位数,MRFS,RFS,CSS,OS为14(95%CI11-17),12(95%CI10-16),10(95%CI8-12),23(95%CI18-33),和16个月(95%CI12-19),分别。关于多变量Cox回归分析,pT3-4阶段,pN+阶段,多焦PSM是LRFS的独立预测因子,MRFS,RFS,和OS。辅助化疗改善了所有研究的肿瘤预后(p<0.05)。淋巴结切除的数量与更好的LRFS独立相关,MRFS,和RFS。诊断时高龄与OS恶化独立相关。
结论:在RC后患有PSM的患者预后较差,因为其中一半会在一年内复发并死于疾病。在所有PSM类型中,多灶性PSM患者预后最差。我们观察到辅助化疗的益处,但评估这些患者创新辅助治疗策略的临床试验仍未满足需求.
Introduction: Adjuvant therapy has no defined role for patients with positive surgical
margins (PSMs) following radical cystectomy (RC) for muscle-invasive bladder cancer (MIBC). The aim of our
study was to describe loco-regional recurrence-free survival (LRFS), metastatic-free survival (MFS), recurrence-free survival (RFS), cancer-specific survival (CSS) and overall survival (OS) and identify predictors of each endpoint in patients with PSMs following RC for MIBC. Methods: A collaborative retrospective cohort
study was conducted on 394 patients with PSMs who underwent RC for MIBC between January 2000 and December 2018 at 10 tertiary referral centers. Patients receiving perioperative radiotherapy were excluded from the
study. Kaplan−Meier curves were used to estimate patient survival. Cox regression analysis was used to identify predictors of survival. Results: Median age at surgery was 70 years (IQR 62−76) with 129 (33%) and 204 (52%) patients had pT3 and pT4 tumors, respectively. Nodal metastasis (pN+) was identified in 148 (38%). Soft tissue PSMs were found in 283 (72%) patients, urethral PSMs in 65 (16.5%), and ureteral PSMs were found in 73 (18.5%). The median follow-up time was 44 months (95% CI 32−60). Median LRFS, MRFS, RFS, CSS, and OS were 14 (95% CI 11−17), 12 (95% CI 10−16), 10 (95% CI 8−12), 23 (95% CI 18−33), and 16 months (95% CI 12−19), respectively. On multivariable Cox regression analysis, the pT3−4 stage, pN+ stage, and multifocal PSMs were independent predictors of LRFS, MRFS, RFS, and OS. Adjuvant chemotherapy improved all oncological outcomes studied (p < 0.05). The number of lymph nodes removed was independently associated with better LRFS, MRFS, and RFS. Advanced age at diagnosis was independently associated with worse OS. Conclusion: Patients with PSMs following RC have poor outcomes since half of them will recur within a year and will die of their disease. Among all PSMs types, patients with multifocal PSMs harbor the worst prognosis. We observed a benefit of adjuvant chemotherapy, but clinical trials evaluating innovative adjuvant strategies for these patients remain an unmet need.